MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Anesthesiology

DIASTAT VASCULAR ACCESS GRAFT

FDA 510(k)

FDA Class 2 ·Cardiovascular

SPINEMED

FDA 510(k)

FDA Class 2 ·Physical Medicine

ReDs Wearable System

FDA 510(k)

FDA Class 2 ·Cardiovascular

PEERSCOPE SYSTEM

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

PillCam Patency System

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology

GraftMax Button, ALB with Cradle, GraftMax Button, BTB with Cradle

FDA 510(k)

FDA Class 2 ·Orthopedic

VITROS CHEMISTRY PRODUCTS ALB SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 4

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Bone Sonometer

FDA Pre-Market Approval

FDA Class 2 ·MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM

ReWalk P6.0

FDA 510(k)

FDA Class 2 ·Physical Medicine

INNOVASA STAT*SEAL TOPICAL HEMOSTAT

FDA 510(k)

FDA Class 2 ·Cardiovascular

BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS

FDA 510(k)

FDA Class 2 ·Ophthalmic

CONSULTIVA REPORT STATION, MODEL RS-1

FDA 510(k)

FDA Class 2 ·Radiology

Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·ORAQUICK HCV RAPID ANTIBODY TEST

ReDS System

FDA 510(k)

FDA Class 2 ·Cardiovascular

VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

MILLS COLUMELLA PROSTHESIS

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

BARLE TISSUE ADHESIVE 2

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

ENDOLYMPHATIC SAC TO MASTOID T-SHUNT

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat